Actinic KeratosisPhase 2NCT00991861
Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis
A Phase 2 study testing LAS41007 o.d., LAS41007 b.i.d. and LAS106521 in people with Actinic Keratosis, run by Almirall, S.A. at 1 site in Germany.
Trial summary
The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- LAS41007 o.d., LAS41007 b.i.d. and LAS106521
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Feb 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp
- The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm
- The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area
Who cannot join
- Have evidence of clinically significant or unstable medical conditions such as:
- metastatic tumor or tumor with high probability of metastatic spread
- heart failure (NYHA class III or higher)
- immunosuppressive disorder (e.g. HIV)
- hematologic, hepatic, renal, neurologic or endocrine disorder.
- collagen-vascular disorder (e.g. cerebrovascular disorder or other bleedings).
Show all 9Show fewer
- gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage)
- Suffer from paresthesia in the treatment areas
- Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41007 Once Daily and LAS41007 Twice Daily Versus LAS106521 Gel Twice Daily in the Treatment of Actinic Keratosis Grade I to II
The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.
- Conditions
- Actinic Keratosis
- Being tested
- LAS41007 o.d., LAS41007 b.i.d., LAS106521
- Keywords
- Actinic Keratosis, AK, NMSC
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS41007 o.d.Drug
Once daily, topical application
LAS41007 b.i.d.Drug
Twice daily, topical application
LAS106521Drug
Twice daily, topical application
| Study group | Role | What they receive |
|---|---|---|
| LAS41007 o.d. | Experimental | Once daily Receives: Drug: LAS41007 o.d. |
| LAS41007 b.i.d. | Experimental | Twice daily Receives: Drug: LAS41007 b.i.d. |
| LAS106521 | Active comparator | Not described Receives: Drug: LAS106521 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological clearance of one pre-selected target lesion
Measured: Day 120
Complete clinical clearance of all target lesions in the treatment areas
Measured: Day 120
Secondary outcomes (1)
Physician's Global Tolerability Assessment (PGT)
Measured: Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Willers, MD, MBA, Study director, Almirall Hermal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991861
- Sponsor's protocol ID
- H 569 000 - 0908
- Other IDs
- EudraCT: 2009-012063-33
- Status last verified
- May 2015
- First submitted
- 7 Oct 2009
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41007 Once Daily and LAS41007 Twice Daily Versus LAS106521 Gel Twice Daily in the Treatment of Actinic Keratosis Grade I to II
- ClinicalTrials.gov ID
- NCT00991861
- Acronym / sponsor ID
- H 569 000 - 0908
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, AK, NMSC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LAS41007 o.d. | Experimental | Drug: LAS41007 o.d.Once daily |
| LAS41007 b.i.d. | Experimental | Drug: LAS41007 b.i.d.Twice daily |
| LAS106521 | Active comparator | Drug: LAS106521 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp
- The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm
- The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area
Key exclusion criteria (9 listed)
- Have evidence of clinically significant or unstable medical conditions such as:
- Suffer from paresthesia in the treatment areas
- Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAS41007 o.d.Once daily, topical application | Drug | LAS41007 o.d. |
| LAS41007 b.i.d.Twice daily, topical application | Drug | LAS41007 b.i.d. |
| LAS106521Twice daily, topical application | Drug | LAS106521 |
Primary outcome
Histological clearance of one pre-selected target lesion
Time frame: Day 120
Complete clinical clearance of all target lesions in the treatment areas
Time frame: Day 120
1 secondary outcome
Physician's Global Tolerability Assessment (PGT)
Time frame: Day 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Almirall Corporate WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Willers, MD, MBA study director
Almirall Hermal GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAS41007 o.d., LAS41007 b.i.d. and LAS106521 in people with Actinic Keratosis, run by Almirall, S.A. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological clearance of one pre-selected target lesion (time frame: Day 120). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.